TORONTO, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. ("Spectral" or the "Company") (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has received the US$3 million Tranche B advance from Vantive US Healthcare LLC ("Vantive") pursuant to the previously disclosed senior secured promissory note entered into in May 2025.
The Tranche B advance further strengthens Spectral's balance sheet and will be used to support ongoing regulatory and commercialization preparations, as well as general working capital requirements. Spectral does not anticipate requiring any additional funding - beyond the fully drawn senior secured promissory note as previously disclosed - to meet its upcoming key milestones, including U.S. FDA submission, and through to PMX commercialization.
"We appreciate Vantive's continued support and are pleased to have closed the Tranche B advance," said Chris Seto, Chief Executive Officer of Spectral Medical. "This non-dilutive capital enhances our liquidity and provides additional flexibility as we execute on our regulatory pathway and commercialization plans. With this funding in place, we remain focused on operational priorities."
Under the terms of the promissory note, Vantive may advance funds up to US$10 million to Spectral in up to four separate tranches to support Spectral's continued evidence generation strategy and path to commercialization of Toraymyxin ("PMX"). With the US$3 million Tranche B advance, together with the initial US$4 million Tranche A advance, the current cumulative draw of the promissory note is US$7 million.
A copy of the Agreement has been filed under Spectral's profile on SEDAR+ at www.sedarplus.ca.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin ("PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's FDA cleared Endotoxin Activity Assay (EAA), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials".
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
| Ali Mahdavi | Chris Seto | |
| Capital Markets & Investor Relations | CEO | |
| Spinnaker Capital Markets Inc. | Spectral Medical Inc. | |
| 416-962-3300 | ||
| am@spinnakercmi.com | cseto@spectraldx.com |
